Drug Approval Package: FULVESTRANT

Company: TEVA Pharmaceuticals USA, Inc.
Application Number: 210063
Approval Date: 08/19/2019

Drugs@FDA information available about FULVESTRANT

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FDA Approval Letter and Labeling

• Approval Letter(s) (PDF)
• Printed Labeling (PDF)

FDA Application Review Files

• Product Quality Review(s) (PDF)
• Clinical Pharmacology and Biopharmaceutics Review(s) (PDF)
• Clinical Review(s) (PDF)
• Other Action Letters (PDF)
• Non-Clinical Review(s) (PDF)
• Officer/Employee List (PDF)
• Other Review(s) (PDF)
• Summary Review (PDF)

Date created: March 12, 2020

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